RECOVERY COVID-19 phase 3 trial to evaluate Regeneron’s REGN-COV2 antibody cocktail

Regeneron Pharmaceuticals, Inc. and the University of Oxford today announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world’s largest randomised clinical trials of potential COVID-19 treatments, will evaluate Regeneron’s investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalised with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.

Peter Horby, Professor of Emerging Infectious Diseases and Global Health, Nuffield Department of Medicine, University of Oxford and chief investigator of the trial, said, 'We have already discovered that one treatment, dexamethasone, benefits COVID-19 patients, but the death rate remains too high so we must keep searching for others. The RECOVERY trial was specifically designed so that when promising investigational drugs such as REGN-COV2 became available they can be tested quickly. We are looking forward to seeing whether REGN-COV2 is safe and effective in the context of a large-scale randomised clinical trial; this is the only way to be certain about whether it works as a treatment for COVID-19.'

'The world urgently needs new medicines to combat COVID-19, and well-designed trials to evaluate new treatment options will quickly help us learn which are most effective,' said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. 'REGN-COV2 was specifically designed by Regeneron scientists to target the virus that causes COVID-19. RECOVERY will be the fourth late-stage randomised clinical trial evaluating REGN-COV2 and will add to our knowledge about how this novel antibody cocktail may help hospitalised patients in need.'

REGN-COV2 is the first specifically designed COVID-19 therapy being evaluated by RECOVERY. It was selected in part based on its emerging safety profile in humans, pre-clinical data showing it could protect against viral escape mutations, and prevention and treatment studies in non-human primates showing it reduced the amount of virus and associated damage in the lungs. REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.

Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, added, 'Throughout the COVID-19 pandemic we have seen the power of randomised trials to provide rigorous assessment of potential treatments. Up to now, we have largely been studying whether existing drugs can be re-purposed to tackle this new disease, but we now have the opportunity to rigorously assess the impact of a drug specifically designed to target this coronavirus. There are good reasons to be excited about this new development – RECOVERY will provide a robust assessment of the effect of this lab-manufactured monoclonal antibody combination treatment in hospitalised patients.

'We are very grateful to the patients who have already taken part in the trial and to those who will participate in this next phase of RECOVERY. We would not be able to find the best treatments without their support and that of the thousands of hospital and research staff who are working with us.'

The open-label RECOVERY trial will assess the impact of adding REGN-COV2 to the usual standard-of-care on all-cause mortality 28 days after randomisation. Other endpoints include the impact on hospital stay and the need for ventilation. It is anticipated that at least 2,000 patients will be randomly allocated to receive REGN-COV2 plus usual standard-of-care, and results will be compared with at least 2,000 patients who receive standard-of-care on its own. Usual standard-of-care varies by local hospital.

The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research, working with clinical teams at 176 hospital sites across the UK.

Deputy Chief Medical Officer Professor Jonathan Van-Tam, said, 'Funded by the UK National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI), RECOVERY is globally recognised as the largest and the most successful COVID-19 platform trial to date. Today’s news is another promising step in the search to find effective treatments, which will improve our ability to deal with this destructive virus, and a testament to the confidence that others around the world have in this brilliantly conceived and executed trial. We’ve had some crucial results from RECOVERY so far, including the life-saving treatment dexamethasone and, as importantly, confirmation that other drugs do not work.

'I look forward to seeing how REGN-COV2 performs in clinical trials, and I urge people to volunteer in this research which could ultimately save many lives.'

Professor Fiona Watt, Executive Chair of the Medical Research Council, said, 'With our support, the RECOVERY trial has previously found the most clinically effective treatment for Covid-19 so far, dexamethasone. The same UK-wide trial will now test a new treatment designed specifically to combat the virus that causes the disease. Monoclonal, or targeted, antibodies are already used to treat cancer and autoimmune diseases. The new trial will tell us whether antibodies that attacks the virus can be an effective treatment for Covid-19.'